MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM

Model Number 101368-67A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 05/23/2019

Event Type  Injury  

Manufacturer Narrative

This report is being submitted retrospectively as part of internal review.Senseonics' medical affairs consultant advised that "if the patient is symptomatic and it is unclear what is wrong, it is justified to remove the sensor as a precautionary measure.Patient sought advice from the diabetologist, cardiologist, pneumonologist, otorhinolaryngologist, and gp and has pre-existing condition, breast cancer.Patient will receive an operation to remove the lymph nodes.The patient revised statement about "coherence of swelling and insertion of sensor" and wants to continue to use the eversense cgm system.No remedial action taken, the sensor will remain in the patient , per the patient's request.The health facility plans to remove lymph nodes from the patient because of a preexisting condition.

Event Description

Senseonics was made aware of an event where the user experienced, red skin, vein burst at the neckline, swollen legs, arms, face,neck and eyes; so bad that she could not really move and found it hard to take a blood sample.She made an emergency call that proceeded a hospital stay.

• Brand Name: EVERSENSE SENSOR
• Type of Device: EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
• Manufacturer (Section D): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer (Section G): SENSEONICS INC.; 20451 seneca meadows parkway; germantown MD 20876 7005
• Manufacturer Contact: vallikannu somasundaram ; 20451 seneca meadows parkway; germantown, MD 20876-7005
• MDR Report Key: 18747315
• MDR Text Key: 335871240
• Report Number: 3009862700-2024-00114
• Device Sequence Number: 1
• Product Code: QCD
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P160048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/24/2019
• Device Model Number: 101368-67A
• Device Catalogue Number: FG-4400-XX-302
• Device Lot Number: WP05150
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other